Forum for Science, Industry and Business

Applying the FDA Definition of Whole Grains Limits the Support for Cardiovascular Disease and Diabetes Health Claims

11.12.2008

LSRO finds insufficient evidence to support a cardiovascular disease or diabetes health claim when considering only studies that conform to the FDA definition of whole grains.

In 2005, cardiovascular disease (CVD) and diabetes were the first and seventh leading causes of death in the U.S., responsible for over 650,000 and 75,000 deaths, respectively.

The 2005 Dietary Guidelines for Americans states that “consuming at least 3 ounce-equivalents of whole grains per day can reduce the risk of coronary heart disease, may help with weight maintenance, and may lower risk for other chronic diseases”. The U.S. Food and Drug Administration (FDA) has allowed food manufacturers to make health claims linking whole grains consumption to CVD risk reduction since 1999. However, it was not until 2006 that the FDA defined whole grains in its guidance to the industry and to assist manufacturers in labeling their products. In this guidance document, FDA defined whole grains as the intact, ground, cracked or flaked fruit of the grains whose principal components—the starchy endosperm, germ and bran—are present in the same relative proportions as they exist in the intact grain.

The Kellogg Company requested that the Life Science Research Office, Inc. (LSRO), www.lsro.org, conduct a third-party, independent evaluation of the effect of strict application of the FDA definition of whole grains on the scientific basis for whole grains health claims. LSRO convened a panel of independent scientists to comprehensively review the relevant scientific literature about whole grains consumption and risks of CVD and diabetes. The Expert Panel’s findings and conclusions are presented in the latest LSRO report entitled, Whole Grain Intake and Cardiovascular Disease and Whole Grain Intake and Diabetes: A Review. The findings and conclusions detailed in the report represent the views of LSRO alone.

Key Findings and Conclusions

Using the FDA definition for whole grains as a selection criterion to evaluate the scientific literature is limiting because most of the studies use a broader concept of whole grains.

The few studies that meet the FDA whole grains definition provide insufficient scientific evidence to support a CVD health claim.

A whole grains and CVD health claim is supported when a larger number of studies that use a broader concept of whole grain that includes isolated bran, germ or fiber in their analysis of whole grains are also considered.

The scientific evidence on risk reduction of diabetes and whole grain consumption is suggestive, but not conclusive, whether or not the study meets the FDA definition of whole grains.

This type of analysis is complicated by the diversity in nutrients and bioactive components of different types of whole grains.

For nearly half a century, the Life Sciences Research Office (LSRO) has provided expert, objective scientific opinions and evaluations to governmental agencies and leading corporations in the food, health and bioscience sectors. A non-profit organization originally established in 1962, LSRO provides independent science-based analysis and advice that has proven integral to the development of sound policies and regulations on the national and international level.

This study will be of interest to academic, government, and industry researchers, public health organizations; public health organizations and their staff. The report will also be of interest to the general public.

A copy of the report is available to the media. A free copy of the executive summary is available online at www.LSRO.org. Purchase this report at www.LSRO.org/bookstore.

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